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Deprecated: Implicit conversion from float 276.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Drugs+R+D 2015 ; 15 (3): 281-91 Nephropedia Template TP
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Population Pharmacokinetics and Pharmacodynamics of GSK961081 (Batefenterol), a Muscarinic Antagonist and ?2-Agonist, in Moderate-to-Severe COPD Patients: Substudy of a Randomized Trial #MMPMID26286203
Drugs R D 2015[Sep]; 15 (3): 281-91 PMID26286203show ga
GSK961081 (batefenterol) is a novel bifunctional molecule composed of a muscarinic antagonist and a ?2?agonist. The aims of this substudy were (1) to characterize the population pharmacokinetics (PK) and pharmacodynamics (PD) of GSK961081 in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD); and (2) to investigate the relationship between systemic exposure to GSK961081 and key cardiac-related safety parameters. Three once-daily doses (100, 400, and 800 ?g) and three twice-daily doses (100, 200, and 400 ?g) of GSK961081 DISKUS were investigated. A two-compartment disposition PK model with first-order absorption adequately described the plasma GSK961081 concentration?time data. An empirical maximum-effects PD model adequately described the forced expiratory volume in 1 s (FEV1) response relationship with the covariate baseline FEV1 on day 1. No clear relationships between GSK961081 plasma drug levels and cardiac-related safety parameters were apparent. The PK and PD models will be used to guide the dose selection and development of GSK961081 in patients with COPD.